All Times EDT
Keywords: adjudication, endpoint
In clinical trials, the primary endpoint must be precisely defined and quantified to minimize noise and possible bias which can potentially lead to incorrect trial conclusions. A Clinical Endpoint Committee (CEC), also known as an Endpoint Adjudication Committee (EAC), is an independent group of experts that reviews clinical trial data in order to give expert opinions about clinical events of interest, blind to treatment allocation. The study statistician provides a crucial role in defining the primary endpoint and providing input to the responsibilities and deliverables of the EAC. Topics for discussion will include which types of studies should utilize an adjudication committee, when is it absolutely necessary to have an adjudication committee, and what would be an acceptable substitute for an EAC that satisfies the same purpose. Also for discussion are the scope of the adjudication activity, the format of the data to be presented to the EAC, and the timing of the adjudication activity relative to study milestones such as study start-up, database lock and statistical analysis.